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Batch Reproducibility and Effect of Gradient Delay Volume on Separation of Impurities of Chlorhexidine Digluconate
Speaker: Dr. Amra Perva
University of Maribor, Faculty of Chemistry and Chemical Engineering
Tuesday, July 23, 2024
10:00 AM - 11:00 AM (PT)
Event Overview:
Chlorhexidine is a disinfectant and antiseptic widely used for skin disinfection prior to surgery, and for cleaning wounds or treating oral infections. The current European Pharmacopeia chlorhexidine digluconate monograph has proved problematic. In this webinar the proposed draft monograph is evaluated, considering multiple batches of HPLC columns, and also the impact of system dwell volume on the overall performance and robustness of the monograph method.
Who Should Attend:
  • Any LC laboratory managers, analysts looking to learn more about Chlorhexidine
Key Learning Points:
  • Find what is it required to achieve system suitability criteria in LC analysis
  • Learn why batch to batch reproducibility test important in method validation 
  • Understand why and when must gradient delay volume be considered 
  • Catch the importance of choosing the “right” column and “correct” gradient elution for separating a great number of impurities
Speaker Bio:
Amra is employed as a research fellow at the Faculty of Chemistry and Chemical Engineering at the University of Maribor (Slovenia).  As the project lead in a GMP certified Contract Research Organization (Group for Separation Analysis) she has over a decade of experience working with pharmaceutical companies in the field of LC and GC method development, validation, stability and release testing for drug substance and drug product.


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